Registration Dossier

Administrative data

Description of key information

For all of the four substances within the amphoteric, glycinate substance group there are available acute oral toxicity data. The endpoint data covers the smallest (shortest alky, lowest number amine and carboxymethylated groups, CAS no 2098351-38-1) as well as the biggest structure (longest alkyl-unsaturated, highest number amine and carboxymethylated groups, CAS no 2060541-49-1) within the group. The studies have been performed under GLP and according to current OECD 401 guideline. In all of the studies the maximum dose tested was 5000 mg/kg bw on the technical products. As the technical products consists of approximately 40 % active ingredient, it is estimated that doses corresponding to 2000 mg a.i./kg bw were tested. The LD50 values are therefore considered to be > 2000 mg a.i./kg bw and no classification for acute oral toxicity is therefore required according to CLP.  

No toxic effects were seen within this dose range for any of the tested substances. This is also in line with the QSAR predictions available on this group of structures. ACD ToxSuite indicates LD50 values > 2000 mg/kg bw for all of the four substances. Within a category of structures the acute toxicity is decreased for longer chain lengths, but increased for alkyl chains with higher unsaturation. This is also predicted by the QSAR models.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: NOTE: PH WAS NEUTRALISED. Performed according to OECD guideline and under GLP.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River.(UK) Limited, Margate, Kent
- Age at study initiation: Young
- Weight at study initiation: Day 1 between 81- 97g
- Fasting period before study: Animals were fasted overnight prior to dosing
- Housing: single sex groups of five in grid bottomed polypropylene cages.
- Diet (e.g. ad libitum): A commercially available pelleted rodent diet (SQC R and M No.1 expanded produced by Special Diet Services, Witham, Essex) ad libitum.
- Water (e.g. ad libitum): mains drinking water via polypropylene bottles were provided ad libitum.
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-61
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: 6 February 1987 - 15 days later
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

DOSAGE PREPARATION (if unusual): The test material was neutralised to a pH of 7.0 using 1.0M citric acid and was then diluted with distilled water to give a dose volume of 20ml/kg at a dose level of 5000mg/kg.
Doses:
5g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were examined frequently after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed at weekly intervals.
- Necropsy of survivors performed: yes, at the end of the fourteen day post dose observation period all animals were weighed and then sacrificed by carbon dioxide asphyxiation. Animals were then subjected to gross examination including the opening of the thoracic and visceral cavities.
Statistics:
Not applicable
Preliminary study:
Not performed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: None of the animals died.
Mortality:
No mortalities observed.
Clinical signs:
No effects of treatment observed.
Body weight:
No effects of treatment observed.
Gross pathology:
No abnormalities noted on necropsy.
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The results of this study indicate that the test material has no toxic effect when administered as a single oral dose to the rat at a dose level of 5000mg/kg bodyweight. The composition of the test material is estimated to be 40% active ingredient (incl NaCl) and 60 % water. Therefore, based on the active ingredient, the tested dose level is considered to be 2000 mg/kg bw based on Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1). The LD50 > 2000 mg/kg bw. NOTE: PH WAS NEUTRALISED.
Executive summary:

An acute oral limit test was performed under GLP and according to OECD 401. Following overnight fasting a group of five male and five female rats were administered the test material, by peroral injection, at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. No effects of treatment were observed throughout the duration of the study and no. abnormalities were detected at necropsy. The results of this study indicate that the technical product consisting of 40% Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1) in aqueous solution has no toxic effect when administered as a single oral dose to the rat at a dose level of 5000mg/kg bodyweight.

Based on the composition of the technical product, the dose level tested is considered to be 2000 mg active ingredient/kg bw based on Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1). Under the conditions of this study the LD50 > 2000 mg a.i./kg bw. NOTE: PH WAS NEUTRALISED.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The available study on Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1) is performed according the available guidelines, under GLP and is considered acceptable for classification and labelling purposes being of reliability rating 1. Also the data on the other three substances within the same group indicates the same lack of toxicity and this is also in line with the QSAR predictions available on this group of structures.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on molecular profiling, dermal absorption is expected to be (much) lower than oral. Taking together the low acute oral toxicity profile within the amphoteric, glycinate group of substances, and the expected low dermal absorption, it is not considered justified from an animal well-fare perspective to perform any additional acute dose toxicity studies. 

 

Acute inhalation toxicity

The measured vapour pressure data on the freeze-dried triamine based amphoteric, glycinate with the shortest alkyl chain (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS number 2060541-51-5) is available and used for the entire group. This value is low and also considered to be a worst case compared to the vapour pressure for the aqueous solutions of the substances which are manufactured, used and put on the marked. Taking together the low acute oral toxicity profile within this group of substances and the low vapour pressure of the aqueous technical product in combination with the low potential for aerosol formation, it is not considered justified from an animal well-fare perspective to perform any additional acute dose toxicity studies. 

Justification for classification or non-classification

The conclusion from the available studies within the group of substances, is that Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1) and the other three substances within the amphoteric, glycinate substane group, are not to be classified for acute toxicity according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008